Metabolomics Profiling of Coronary Heart Disease
LC-MS Based Metabolomics Study of Coronary Heart Disease: Diagnostic and Prognostic Value of Metabolites
1 other identifier
observational
821
1 country
5
Brief Summary
This study sought to assess the diagnostic and prognostic values of metabolomics in coronary artery disease(CAD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
November 17, 2021
CompletedFirst Posted
Study publicly available on registry
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2023
CompletedJanuary 14, 2022
December 1, 2021
2.3 years
November 17, 2021
December 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death
A composite of death from cardiovascular causes in patients with CAD
Follow-up is expected to end on December 30, 2022
Secondary Outcomes (1)
Major adverse cardiovascular events
Follow-up is expected to end on December 30, 2022
Study Arms (7)
Stable angina (SA)
Typical chronic exersive angina pectoris attacks, lasting several minutes to more than 10 minutes, 3-5 minutes in most cases, generally not more than 30 minutes. The pain disappeared after rest or taking nitrates, and the pain degree, frequency, duration, nature and inducing factors did not change in the last 1-3 months.
Unstable angina (UA）
Including resting angina (attack at rest, the duration is usually \>20 minutes), primary angina (usually the first symptoms within 1-2 months, very light physical activity can be induced, at least CCSIII level), worsening angina (angina gradually increases on the basis of relatively stable labor angina. More severe pain, longer or more frequent pain, at least grade I increase according to THE CCS classification, at least GRADE II CCSI). TNI was negative, routine electrocardiogram may have transient ST segment depression, T wave low flat or inverted.
Acute non-ST-segment elevation myocardial infarction （NSTEMI）
Patients with elevated troponin accompanied by one or more of the following conditions: electrocardiogram showed new ST segment depression or T wave flatness or inversion; Persistent ischemic chest pain; Echocardiography showed abnormal segmental ventricular wall activity. Abnormal coronary angiography.
Acute ST-segment elevation myocardial infarction （STEMI）
Troponin was elevated, and ECG showed ST segment arcuate back elevation, accompanied by one or more of the following conditions: persistent ischemic chest pain; Echocardiography showed segmental abnormal ventricular wall activity; Abnormal coronary angiography.
normal coronary artery （NCA）
symptoms of chest pain and no stenosis in coronary arteries (such as myocardial bridging, reflux esophagitis, intercostals neuralgia, cervical spondylopathy, and unexplained chest pain)
nonobstructive coronary atherosclerosis （NOCA）
stenosis \< 50% in coronary arteries
healthy volunteers
Healthy control subjects who had no significant systemic diseases (e.g. ischemic heart disease, hypertension,diabetes,cancer, pulmonary disease, or infectious diseases) were recruited from Physical Examination Center of Ningxia Medical University General Hospital
Interventions
different group intervened with different treatment following guidelines/consensuses accordingly
Eligibility Criteria
About 821 subjects will be recruited from 5 centers in different hospitals.
You may qualify if:
- Objective evidence of coronary heart disease risk factors
- Or angina pectoris symptoms
- Or ECG ischemic changes
- Or elevated myocardial enzymes, myocardial radionuclide scanning showing myocardial filling defect, coronary CT showing coronary stenosis ≥ 50%
You may not qualify if:
- Older than 80 years and younger than 18 years old,
- Aortic dissection
- Pulmonary embolism
- Malignant tumor
- Autoimmune diseases
- Systemic systemic diseases
- Severe infectious diseases
- Trauma, surgery in the last three months
- Myocarditis, cardiomyopathy, pericarditis, severe congenital heart disease
- Syphilis
- Human immunodeficiency virus / acquired immunodeficiency syndrome
- Hepatitis B and hepatitis C
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Department of Cardiovascular Internal Disease, Guyuan People's Hospital of Ningxia Autonomous Region
Guyuan, Ningxia, 756000, China
Fifth People's Hospital of Ningxia Autonomous Region
Shizuishan, Ningxia, 753000, China
Affiliated Cardio-Cerebrovascular Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750000, China
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, 750000, China
Department of Cardiaovascular Internal Disease, General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Related Publications (8)
Iida M, Harada S, Takebayashi T. Application of Metabolomics to Epidemiological Studies of Atherosclerosis and Cardiovascular Disease. J Atheroscler Thromb. 2019 Sep 1;26(9):747-757. doi: 10.5551/jat.RV17036. Epub 2019 Aug 2.
PMID: 31378756BACKGROUNDVaarhorst AA, Verhoeven A, Weller CM, Bohringer S, Goraler S, Meissner A, Deelder AM, Henneman P, Gorgels AP, van den Brandt PA, Schouten LJ, van Greevenbroek MM, Merry AH, Verschuren WM, van den Maagdenberg AM, van Dijk KW, Isaacs A, Boomsma D, Oostra BA, van Duijn CM, Jukema JW, Boer JM, Feskens E, Heijmans BT, Slagboom PE. A metabolomic profile is associated with the risk of incident coronary heart disease. Am Heart J. 2014 Jul;168(1):45-52.e7. doi: 10.1016/j.ahj.2014.01.019. Epub 2014 Apr 4.
PMID: 24952859BACKGROUNDCavus E, Karakas M, Ojeda FM, Kontto J, Veronesi G, Ferrario MM, Linneberg A, Jorgensen T, Meisinger C, Thorand B, Iacoviello L, Bornigen D, Woodward M, Schnabel R, Costanzo S, Tunstall-Pedoe H, Koenig W, Kuulasmaa K, Salomaa V, Blankenberg S, Zeller T; BiomarCaRE consortium. Association of Circulating Metabolites With Risk of Coronary Heart Disease in a European Population: Results From the Biomarkers for Cardiovascular Risk Assessment in Europe (BiomarCaRE) Consortium. JAMA Cardiol. 2019 Dec 1;4(12):1270-1279. doi: 10.1001/jamacardio.2019.4130.
PMID: 31664431BACKGROUNDMcGarrah RW, Crown SB, Zhang GF, Shah SH, Newgard CB. Cardiovascular Metabolomics. Circ Res. 2018 Apr 27;122(9):1238-1258. doi: 10.1161/CIRCRESAHA.117.311002.
PMID: 29700070BACKGROUNDFan Y, Li Y, Chen Y, Zhao YJ, Liu LW, Li J, Wang SL, Alolga RN, Yin Y, Wang XM, Zhao DS, Shen JH, Meng FQ, Zhou X, Xu H, He GP, Lai MD, Li P, Zhu W, Qi LW. Comprehensive Metabolomic Characterization of Coronary Artery Diseases. J Am Coll Cardiol. 2016 Sep 20;68(12):1281-93. doi: 10.1016/j.jacc.2016.06.044.
PMID: 27634119BACKGROUNDHilvo M, Meikle PJ, Pedersen ER, Tell GS, Dhar I, Brenner H, Schottker B, Laaperi M, Kauhanen D, Koistinen KM, Jylha A, Huynh K, Mellett NA, Tonkin AM, Sullivan DR, Simes J, Nestel P, Koenig W, Rothenbacher D, Nygard O, Laaksonen R. Development and validation of a ceramide- and phospholipid-based cardiovascular risk estimation score for coronary artery disease patients. Eur Heart J. 2020 Jan 14;41(3):371-380. doi: 10.1093/eurheartj/ehz387.
PMID: 31209498BACKGROUNDQin M, Zhu Q, Lai W, Ma Q, Liu C, Chen X, Zhang Y, Wang Z, Chen H, Yan H, Lei H, Zhang S, Dong X, Wang H, Huang M, Lian Q, Zhong S. Insights into the prognosis of lipidomic dysregulation for death risk in patients with coronary artery disease. Clin Transl Med. 2020 Sep;10(5):e189. doi: 10.1002/ctm2.189.
PMID: 32997403BACKGROUNDZhang L, Wei TT, Li Y, Li J, Fan Y, Huang FQ, Cai YY, Ma G, Liu JF, Chen QQ, Wang SL, Li H, Alolga RN, Liu B, Zhao DS, Shen JH, Wang XM, Zhu W, Li P, Qi LW. Functional Metabolomics Characterizes a Key Role for N-Acetylneuraminic Acid in Coronary Artery Diseases. Circulation. 2018 Mar 27;137(13):1374-1390. doi: 10.1161/CIRCULATIONAHA.117.031139. Epub 2017 Dec 6.
PMID: 29212895BACKGROUND
Related Links
- Application of Metabolomics to Epidemiological Studies of Atherosclerosis and Cardiovascular Disease
- A metabolomic profile is associated with the risk of incident coronary heart disease
- Association of Circulating Metabolites With Risk of Coronary Heart Disease in a European Population Results From the Biomarkers for Cardiovascular Risk Assessment in Europe (BiomarCaRE) Consortium
- Cardiovascular Metabolomics
- ComprehensiveMetabolomicCharacterization of Coronary Artery Diseases
- Development and validation of a ceramide- and phospholipid-based cardiovascular risk estimation score for coronary artery disease patients
- Insights into the prognosis of lipidomic dysregulation for death risk in patients with coronary artery disease.
- Functional Metabolomics Characterizes a Key Role for N-Acetylneuraminic Acid in Coronary Artery Diseases
Biospecimen
Serum and urine samples from all participants
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hechun Xia, MA
General Hospital of Ningxia Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice director of the department of cardiovascular internal medicine
Study Record Dates
First Submitted
November 17, 2021
First Posted
December 1, 2021
Study Start
October 1, 2020
Primary Completion
January 30, 2023
Study Completion
May 30, 2023
Last Updated
January 14, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share